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Re: RBlatch post# 7642

Wednesday, 07/25/2007 12:50:19 PM

Wednesday, July 25, 2007 12:50:19 PM

Post# of 57585
<<But we all find enough time to get done what absolutely needs to be done, don't we?>>

Sure, and they did. They did all the animal work--some inhouse, some outsourced, and then supervised--necessary to identify, and then document, the 'artifact.' That is what HAD to be done, without it, there would be no IND to Psychiatry. Besides, rushing an IND to Psychiatry at the beginning of August guarantees that the FDA will reset the clock by saying it requires review--since they will be short-staffed due to vacation (and Neurology hasn't completed its review). While it is probably overly optimistic to hope for the 30 days to expire without comment, allowing the trial to go forward, they'll have a better chance of that in September, when everyone is back at the FDA, and can ask each other--do you have any questions? In other words, getting the IND in earlier could actually backfire--especially when Neurology already told them they hadnt read everything yet. Neurology needs to sign off completely, then Psychiatry can deal with it.

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